Phase 3 HARMONi-6/AK112-306 Trial of Ivonescimab Plus Chemotherapy for NSCLC Completes Enrollment

Patient enrollment has been completed in the phase 3 HARMONi-6/AK112-306 trial, according to an announcement from Akeso, Inc.

The study is comparing ivonescimab plus platinum-based chemotherapy with tislelizumab plus platinum-based chemotherapy as a first-line treatment for patients with squamous non–small cell lung cancer (NSCLC). In addition to the HARMONi-6 trial, several international phase 3 trials of ivonescimab are underway, including the HARMONi-3 clinical trial, which compares ivonescimab plus chemotherapy to pembrolizumab plus chemotherapy for the first-line treatment of both squamous and nonsquamous NSCLC.

The HARMONi-6/AK112-306 trial is one of six registrational/phase 3 trials that are evaluating ivonescimab for lung cancer and is also one of six studies in which programmed cell death 1 (PD-1)/programmed cell death ligand 1 (PD-L1) inhibitors are used as comparators.

“This initiative is a critical step in advancing cancer immunotherapy, establishing superior global treatment standards, and exploring the full clinical and commercial potential of ivonescimab within Akeso’s portfolio,” officials said in the announcement.

Ivonescimab plus chemotherapy is approved in China for the treatment of patients with nonsquamous NSCLC that is resistant to EGFR tyrosine kinase inhibitors. A New Drug Application for ivonescimab monotherapy as a first-line treatment for PD-L1–positive NSCLC is currently under review and has been granted priority status in China, officials said.

Source: PR Newswire